A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 to 12 Years) With Attention-Deficit Hyperactivity Disorder

Trial Profile

A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 to 12 Years) With Attention-Deficit Hyperactivity Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2017

At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Neos Therapeutics
  • Most Recent Events

    • 19 Jun 2017 According to Neos Therapeutics media release, based on the results from this study the U.S. FDA approved Cotempla XR-ODT orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old.
    • 19 Jun 2017 Results published in the Neos Therapeutics media release.
    • 20 Dec 2016 According to Neos Therapeutics media release, the company has announced that it has completed the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Cotempla XR-ODT.
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